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Preparation method of alanyl-glutamine freeze-dried powder

A technology of alanyl glutamine and freeze-dried powder, which is applied in the direction of freeze-dried transportation, powder transportation, metabolic diseases, etc., can solve problems such as incomplete grasp, unsatisfactory effect, error in product accuracy, etc., to achieve applicable Wide range, good product precision and production effect, and the effect of improving precision

Active Publication Date: 2014-03-05
HAINAN GENERAL & KANGLI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Alanyl glutamine is a component of parenteral nutrition, suitable for patients who need to supplement glutamine, including patients in catabolic and hypermetabolism conditions, alanyl glutamine is usually made into lyophilized powder for preservation At present, in the preparation of alanyl glutamine freeze-dried powder, due to the limitation of the process method, different preparation methods usually have different applicable production scales. Therefore, if the production scale is adjusted, it is often necessary to make certain adjustments to the process. At the same time, due to the inaccurate grasp of some details in the traditional preparation method, there are often errors in the accuracy of the product, and the effect is not very ideal. Therefore, it is necessary to adapt to different production scales and have high precision. Good preparation method

Method used

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Examples

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Comparison scheme
Effect test

Embodiment 1

[0024] According to the content disclosed in the present invention, the following operations are carried out, wherein the dosage of alanyl glutamine is 10000g, water for injection is 25000g, and the preparation amount of medicinal activated carbon is 0.2% (w / w):

[0025] a. Add 50% water for injection into the liquid preparation tank, and cool to 40-60°C;

[0026] b. Then add the approved amount of alanyl glutamine and stir until completely dissolved, then add water for injection to the full amount;

[0027] c. Add the prepared amount of 0.2% (w / w) activated carbon, and circulate for 30 minutes while stirring to obtain the medicinal solution A;

[0028] d. Use a pump to filter liquid medicine A through 0.45 μm and 0.22 μm microporous filter elements first, then take a sample and test to make the pH range 5.4-6.0, and then carry out fine filtration with 0.22 μm microporous membrane to obtain liquid medicine B. Liquid medicine B is transported to the sterilized stainless steel ...

Embodiment 2

[0035] Embodiment 2 adopts the same process and steps as in Example 1. The difference is that in Example 2, the amount of medicinal ingredients is different from Example 1. In Example 2, it is: alanylglutamine 40Kg, water for injection 100Kg, the preparation amount of medicinal activated carbon is 0.2% (w / w), and finally the finished product 2 is obtained.

[0036] Finished product 1 and finished product 2 adopt different production scales in the preparation process, but both obtain finished products with stable quality. Through the preparation of the above process, the quality of finished product 1 and finished product 2 is more stable, the precision is improved, and the whole process is easy to control , suitable for promotion.

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Abstract

The invention discloses a preparation method of alanyl-glutamine freeze-dried powder. By improving and regulating the conventional preparation method, adjusting a component adding sequence, controlling temperature more precisely, increasing a refined filtration layer, and the like, finished product quality is more stable, and precision is improved. And moreover, the preparation method further can be adapted to different-scale production, and is wider in scope of application.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a preparation method of alanyl glutamine freeze-dried powder. Background technique [0002] Alanyl glutamine, molecular formula C 8 h 15 N 3 o 4 , as white or off-white loose lumps. Alanyl glutamine is a component of parenteral nutrition, suitable for patients who need to supplement glutamine, including patients in catabolic and hypermetabolism conditions, alanyl glutamine is usually made into lyophilized powder for preservation At present, in the preparation of alanyl glutamine freeze-dried powder, due to the limitation of the process method, different preparation methods usually have different applicable production scales. Therefore, if the production scale is adjusted, it is often necessary to make certain adjustments to the process. At the same time, due to the inaccurate grasp of some details in the traditional preparation method, there are often errors in the accuracy of the pr...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K38/05A61P3/02
Inventor 王志涛林密林小雪
Owner HAINAN GENERAL & KANGLI PHARMA
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